Senior Manager, Facilities and Equipment Qualification

Band

Level 4

 

Job Description Summary

#LI-Onsite

This position is based on the East Hanover, NJ campus and cannot be located remotely.

About the role:

The Senior Manager Qualification is responsible for ensuring compliance to the regulatory requirements of the facilities, utilities, equipment and analytical instruments qualification processes and activities performed in the Engineering department of the Novartis, Cell and Gene Therapy East Hanover, NJ facility. Recommends and implements improvements of the qualification process. Performs a variety of routine and non-routine tasks related to facilities, utilities, equipment, and analytical instruments qualification, as managing, and overlooking qualification program, projects, and changes. Reviews and approves qualification documents such as installation, operational, performance qualification (IOPQ) and computer software validation (CSV) protocols, reports, traceability matrix (TM). Prepares and/or approves risk and impact assessments, validation master plans (VMP) and other evaluations. Supports Production Unit (PU), Technical Development (TD), Operations (OPS), Quality Control (QC) and Quality Assurance (QA) departments. Plans and manages qualification activities of manufacturing equipment, laboratory instruments, facilities, and utilities. Ensures efficient, timely, GMP and compliant execution of qualification activities. Manages internal Qualification Engineers and provides oversight of 3rd party qualification service provider contracts.

 

Job Description

Key Responsibilities:

-Manages qualification program:

• Manage qualification activities in compliance with corporate policy, local procedures, and regulatory expectations.
• Determines qualification requirements based on a worst-case matrix approach for the site.
• Manage and develop, in alignment with Production, Analytical Operations (QC), Quality Assurance (QA), and Analytical / Process Development teams, qualification projects and plans and identifies the “critical to quality” parameters impacting qualification activities.

-Prepares and/or approves Qualification Master Plans, risk and impact assessments, protocols and summary reports and coordinates review and approvals of the documents.

-Reviews/approves/manages executed installation, operational, performance qualification (IOPQ) and computer system validation (CSV) protocols, Periodic Reviews and Requalification.

-Authors/reviews/updates/assists in developing departmental standard operating procedures (SOPs), Work Procedures (WP) and qualification programs.

Ensures that all activities are in compliance with cGMP, Health Authority regulations and the Novartis Policies.

-Supports and provides oversight of 3rd party/ vendor qualification activities, if applicable.

Assists in investigation of Out of Specification (OOS), Out of Expectations (OOE), product deviations. or rejects related to equipment, laboratory instruments, facilities, and utilities in area of responsibility.

Trains colleagues and external employees on qualification and validation practices.

Essential Requirements:

•  Education: BS degree in scientific discipline or engineering or equivalent experience.
• 7+years of Pharmaceutical Industry facility, utility and cell/gene production equipment & laboratory instrument qualification and CSV experience or applicable experience in a related area in the pharmaceutical industry.
• Knowledge of cGMPs and understanding of the concepts of GLP, FDA and Health Authority guidelines, applicable regulations and standards routinely used in the industry (ANSI, ISO, GAMP, ATMP).
• Thorough understanding of environmental control programs and aseptic manufacturing areas.
• Supervisory or management experience: may include leading teams or projects.
• GMP Qualification & Validation Project Management and Computer system Validation (CSV)12. Highly knowledgeable in cGMP and regulatory requirements, including CSV requirements and 21 CFR Part 11 compliance. 8. Detailed understanding of quality assurance standards, principles, theories, and technique.

Skills required:

• Technical skills in the understanding of pharmaceutical facilities, utilities, manufacturing, and laboratory equipment/instruments operation.
• Team Building / People Challenges / Collaborating across boundaries
• Interpersonal and operational savvy / Good communication and negotiations skills.
• Strong technical writing skills for generating high quality protocols & technical reports
• Good project management skills, decision-making ability.
• Stakeholder Engagement.
• Must be able to work independently.
• Root Cause